Tri-luma Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Adverse events may be more likely with exposure during organogenesis in the first trimester.
Animal models have revealed evidence of in utero deaths, increased numbers of stillborn pups, decreased fetal weights, delayed preputial separation, and teratogenicity (e.g., cleft palate, protruding tongue, open eyes, umbilical hernia, retinal folding/dysplasia). Animal models given tretinoin or fluocinolone have revealed evidence of teratogenicity. There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
Tri-luma Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Yes (fluocinolone); Unknown (hydroquinone, tretinoin)
Comments:
-The effects in the nursing infant are unknown.
-If this drug is used during breastfeeding, patients should ensure that infants do not come into contact with treated areas.
See references
